Date: 2014-12-15
Type of information: Publication of results in a medical journal
phase: 2
Announcement: publication of results in the Lancet Oncology
Company: Pfizer (USA - NY)
Product: palbociclib
Action
mechanism: Palbociclib is an investigational oral targeted agent that selectively inhibits cyclin-dependent kinases (CDKs) 4 and 6 to regain cell cycle control and block tumor cell proliferation.
Disease: estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On December 15, 2014, Pfizer announced the publication of the detailed results from PALOMA-1, a randomized Phase 2 study of palbociclib in combination with letrozole versus letrozole alone, in The Lancet Oncology. As previously disclosed, PALOMA-1 achieved its primary endpoint with the combination of palbociclib and letrozole significantly prolonging progression-free survival (PFS) compared with letrozole alone in post-menopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer. A New Drug Application (NDA) for palbociclib was accepted for filing and granted Priority Review by the FDA. This NDA is based on the final results of PALOMA-1. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 13, 2015. Ibrance® is the proposed trade name for palbociclib. Results from PALOMA-1 were presented by lead author Dr. Richard Finn at the American Association for Cancer Research (AACR) Annual Meeting 2014. PALOMA-1 was conducted in collaboration with the Jonsson Comprehensive Cancer Center’s Revlon/UCLA Women’s Cancer Research Program, led by Dr. Dennis Slamon.
